510(k) K854314 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
FANA 60
| Applicant | American Bio-Reagents, Inc., Easton PA, US |
| Decision | Substantially Equivalent, Dec 16, 1985 |
| Received | Oct 28, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854314
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.